McNeil Recalls Motrin Drops After Plastic is Found in Ingredient - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

McNeil Recalls Motrin Drops After Plastic is Found in Ingredient


McNeil Consumer Healthcare Division of McNeil-PPC announced on Sept. 6 a voluntary recall at the retail level of three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor (0.5 fl oz bottles) after 1 mm plastic particles were identified in a different product lot during manufacturing.  The lot in which the particles were discovered was not released to the market.

In a press statement posted on www.FDA.gov and the McNeil website, the company reported that the particles originated in a shipment from a third-party supplier of ibuprofen, the active ingredient in the recalled product.  The company said that, out of an abundance of caution, it was recalling the three lots—approximately 200,000 bottles distributed in the United States—that were made with the same batch of active ingredient.  

The company says it has worked with the third party to ensure that corrective measures are currently in place and the potential for adverse medical events related to the reason for this recall is not likely.   

McNeil is asking retailers to remove the affected lots from store shelves and is asking consumers to stop using and dispose of any product they may have that is included in this recall.

Sources: FDA and McNeil Consumer Healthcare Division of McNeil-PPC

 

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy

Click here